Left atrial appendage implant

ABSTRACT

An implant for occluding a left atrial appendage may include an expandable framework configured to shift between a collapsed configuration and an expanded configuration. The expandable framework includes a proximal hub and a distal hub. A longitudinal axis of the expandable framework extends from the proximal hub to the distal hub. A radiopaque marker may be positioned longitudinally between the proximal hub and the distal hub in the expanded configuration.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority of U.S. ProvisionalApplication No. 63/213,696 filed Jun. 22, 2021, the entire disclosure ofwhich is hereby incorporated by reference.

TECHNICAL FIELD

The disclosure relates generally to medical devices and moreparticularly to medical devices that are adapted for use in percutaneousmedical procedures including implantation into the left atrial appendage(LAA) of a heart.

BACKGROUND

The left atrial appendage is a small organ attached to the left atriumof the heart. During normal heart function, as the left atriumconstricts and forces blood into the left ventricle, the left atrialappendage constricts and forces blood into the left atrium. The abilityof the left atrial appendage to contract assists with improved fillingof the left ventricle, thereby playing a role in maintaining cardiacoutput. However, in patients suffering from atrial fibrillation, theleft atrial appendage may not properly contract or empty, causingstagnant blood to pool within its interior, which can lead to theundesirable formation of thrombi within the left atrial appendage.

Thrombi forming in the left atrial appendage may break loose from thisarea and enter the blood stream. Thrombi that migrate through the bloodvessels may eventually plug a smaller vessel downstream and therebycontribute to stroke or heart attack. Clinical studies have shown thatthe majority of blood clots in patients with atrial fibrillationoriginate in the left atrial appendage. As a treatment, medical deviceshave been developed which are deployed to close off the left atrialappendage. Of the known medical devices and methods, each has certainadvantages and disadvantages. There is an ongoing need to providealternative medical devices as well as alternative methods formanufacturing and using medical devices.

SUMMARY

In one example, an implant for occluding a left atrial appendage maycomprise an expandable framework configured to shift between a collapsedconfiguration and an expanded configuration, wherein the expandableframework includes a proximal hub and a distal hub, wherein alongitudinal axis of the expandable framework extends from the proximalhub to the distal hub, and a radiopaque marker positioned longitudinallybetween the proximal hub and the distal hub in the expandedconfiguration.

In addition or alternatively to any example disclosed herein, theradiopaque marker is oriented longitudinally in the expandedconfiguration.

In addition or alternatively to any example disclosed herein, theradiopaque marker includes a body portion, a proximal leg, a distal leg,a first lateral tab, and a second lateral tab. The body portion isdisposed against an exterior surface of the expandable framework.

In addition or alternatively to any example disclosed herein, theproximal leg and the distal leg extend radially inwardly toward aninterior of the expandable framework.

In addition or alternatively to any example disclosed herein, the firstlateral tab and the second lateral tab wrap around a portion of theexpandable framework.

In addition or alternatively to any example disclosed herein, theradiopaque marker includes a tubular member disposed radially inward ofand secured against an inner surface of the expandable framework.

In addition or alternatively to any example disclosed herein, theradiopaque marker includes a flat plate disposed radially inward of andsecured against an inner surface of the expandable framework.

In addition or alternatively to any example disclosed herein, theimplant may further comprise an occlusive element disposed over at leasta portion of the expandable framework.

In addition or alternatively to any example disclosed herein, theradiopaque marker includes a flattened element at least partiallyembedded within the occlusive element.

In addition or alternatively to any example disclosed herein, theradiopaque marker includes a plurality of radiopaque markers spacedapart about a circumference of the expandable framework.

In addition or alternatively to any example disclosed herein, a systemfor occluding a left atrial appendage may comprise a delivery sheath andcore wire slidably disposed within a lumen of the delivery sheath and animplant for occluding a left atrial appendage releasably securable to adistal end of the core wire. The implant may comprise an expandableframework configured to shift between a collapsed configuration and anexpanded configuration, wherein the expandable framework includes aproximal hub and a distal hub, wherein a longitudinal axis of theexpandable framework extends from the proximal hub to the distal hub,and a radiopaque marker positioned longitudinally between the proximalhub and the distal hub in the expanded configuration.

In addition or alternatively to any example disclosed herein, theradiopaque marker is formed from a different material than theexpandable framework.

In addition or alternatively to any example disclosed herein, theradiopaque marker has a different density than the expandable framework.

In addition or alternatively to any example disclosed herein, theradiopaque marker includes a body portion, a proximal leg, and a distalleg. The body portion is disposed against an exterior surface of theexpandable framework. The proximal leg and the distal leg extendradially inwardly toward an interior of the expandable framework. Whenthe implant is being moved into the lumen, the proximal leg engages thedelivery sheath to urge the expandable framework radially inward andaway from the delivery sheath.

In addition or alternatively to any example disclosed herein, a systemfor occluding a left atrial appendage may comprise a delivery sheath anda core wire slidably disposed within a lumen of the delivery sheath andan implant for occluding a left atrial appendage releasably securable toa distal end of the core wire. The implant may comprise an expandableframework configured to shift between a collapsed configuration and anexpanded configuration, wherein the expandable framework includes aproximal hub and a distal hub, wherein a longitudinal axis of theexpandable framework extends from the proximal hub to the distal hub, afirst radiopaque marker positioned longitudinally between the proximalhub and the distal hub in the expanded configuration, a secondradiopaque marker positioned longitudinally between the proximal hub andthe distal hub in the expanded configuration, and a third radiopaquemarker positioned longitudinally between the proximal hub and the distalhub in the expanded configuration. The first radiopaque marker, thesecond radiopaque marker, and the third radiopaque marker may define aplane for positioning the expandable framework relative to an ostium ofthe left atrial appendage in the expanded configuration.

In addition or alternatively to any example disclosed herein, the first,second, and third radiopaque markers each includes a body portion, aproximal leg, and a distal leg. The body portion is disposed against anexterior surface of the expandable framework. The proximal leg and thedistal leg extend radially inwardly toward an interior of the expandableframework. When the implant is being moved into the lumen, the proximalleg engages the delivery sheath to urge the expandable frameworkradially inward and away from the delivery sheath.

In addition or alternatively to any example disclosed herein, the first,second, and third radiopaque markers each further includes a firstlateral tab and a second lateral tab. The first lateral tab and thesecond lateral tab wrap around a portion of the expandable framework.

In addition or alternatively to any example disclosed herein, at least aportion of the second lateral tab overlaps the first lateral tab.

In addition or alternatively to any example disclosed herein, at least aportion of the second lateral tab extends radially inward closer to thelongitudinal axis than the first lateral tab.

In addition or alternatively to any example disclosed herein, the first,second, and third radiopaque markers each define a lateral extent and alongitudinal extent, the longitudinal extent being greater than thelateral extent. The longitudinal extent is oriented longitudinally withrespect to the expandable framework.

The above summary of some embodiments, aspects, and/or examples is notintended to describe each embodiment or every implementation of thepresent disclosure. The figures and the detailed description moreparticularly exemplify aspects of these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of thefollowing detailed description in connection with the accompanyingdrawings, in which:

FIGS. 1-2 are side views of an example system for occluding a leftatrial appendage;

FIGS. 3-4 illustrate selected aspects of an implant for occluding a leftatrial appendage;

FIG. 5 illustrates the implant of FIGS. 3-4 disposed within a leftatrial appendage;

FIG. 6 illustrates aspects of a radiopaque marker of the implant of FIG.3 ;

FIG. 7 is a cross-sectional view illustrating aspects of the radiopaquemarker of FIG. 6 ;

FIG. 8 is a side view illustrating aspects of the radiopaque marker ofFIG. 6 ;

FIG. 9 illustrates selected aspects of the implant of FIG. 3 being movedinto the outer sheath of FIGS. 1-2 ;

FIG. 10 illustrates an alternative configuration of a radiopaque markerfor the implant of FIG. 3 ;

FIG. 11 illustrates an alternative configuration of a radiopaque markerfor the implant of FIG. 3 ; and

FIGS. 12-13 illustrate an alternative configuration of a radiopaquemarker for the implant of FIG. 3 .

While aspects of the disclosure are amenable to various modificationsand alternative forms, examples are shown in the drawings and describedherein. It should be understood, however, that the intention is not tolimit aspects of the disclosure to the particular embodiments described.On the contrary, the disclosure shall cover all modifications,equivalents, and alternatives falling within the spirit and scopethereof.

DETAILED DESCRIPTION

The following description should be read with reference to the drawings,which are not necessarily to scale, wherein like reference numeralsindicate like elements throughout the several views. The detaileddescription and drawings are intended to illustrate but not limit thepresent disclosure. Those skilled in the art will recognize that thevarious elements described and/or shown may be arranged in variouscombinations and configurations without departing from the scope of thedisclosure. The detailed description and drawings illustrate exampleembodiments of the disclosure. However, in the interest of clarity andease of understanding, while every feature and/or element may not beshown in each drawing, the feature(s) and/or element(s) may beunderstood to be present regardless, unless otherwise specified.

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about”, in thecontext of numeric values, generally refers to a range of numbers thatone of skill in the art would consider equivalent to the recited value(e.g., having the same function or result). In many instances, the term“about” may include numbers that are rounded to the nearest significantfigure. Other uses of the term “about” (e.g., in a context other thannumeric values) may be assumed to have their ordinary and customarydefinition(s), as understood from and consistent with the context of thespecification, unless otherwise specified.

The recitation of numerical ranges by endpoints includes all numberswithin that range, including the endpoints (e.g., 1 to 5 includes 1,1.5, 2, 2.75, 3, 3.80, 4, and 5).

Although some suitable dimensions, ranges, and/or values pertaining tovarious components, features and/or specifications are disclosed, one ofskill in the art, incited by the present disclosure, would understanddesired dimensions, ranges, and/or values may deviate from thoseexpressly disclosed.

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise. It isto be noted that in order to facilitate understanding, certain featuresof the disclosure may be described in the singular, even though thosefeatures may be plural or recurring within the disclosed embodiment(s).Each instance of the features may include and/or be encompassed by thesingular disclosure(s), unless expressly stated to the contrary. Forsimplicity and clarity purposes, not all elements of the presentdisclosure are necessarily shown in each figure or discussed in detailbelow. However, it will be understood that the following discussion mayapply equally to any and/or all of the components for which there aremore than one, unless explicitly stated to the contrary. Additionally,not all instances of some elements or features may be shown in eachfigure for clarity.

Relative terms such as “proximal”, “distal”, “advance”, “retract”,variants thereof, and the like, may be generally considered with respectto the positioning, direction, and/or operation of various elementsrelative to a user/operator/manipulator of the device, wherein“proximal” and “retract” indicate or refer to closer to or toward theuser and “distal” and “advance” indicate or refer to farther from oraway from the user. In some instances, the terms “proximal” and “distal”may be arbitrarily assigned in an effort to facilitate understanding ofthe disclosure, and such instances will be readily apparent to theskilled artisan. Other relative terms, such as “upstream”, “downstream”,“inflow”, and “outflow” refer to a direction of fluid flow within alumen, such as a body lumen, a blood vessel, or within a device. Stillother relative terms, such as “axial”, “circumferential”,“longitudinal”, “lateral”, “radial”, etc. and/or variants thereofgenerally refer to direction and/or orientation relative to a centrallongitudinal axis of the disclosed structure or device.

The term “extent” may be understood to mean a greatest measurement of astated or identified dimension, unless the extent or dimension inquestion is preceded by or identified as a “minimum”, which may beunderstood to mean a smallest measurement of the stated or identifieddimension. For example, “outer extent” may be understood to mean anouter dimension, “radial extent” may be understood to mean a radialdimension, “longitudinal extent” may be understood to mean alongitudinal dimension, etc. Each instance of an “extent” may bedifferent (e.g., axial, longitudinal, lateral, radial, circumferential,etc.) and will be apparent to the skilled person from the context of theindividual usage. Generally, an “extent” may be considered a greatestpossible dimension measured according to the intended usage, while a“minimum extent” may be considered a smallest possible dimensionmeasured according to the intended usage. In some instances, an “extent”may generally be measured orthogonally within a plane and/orcross-section, but may be, as will be apparent from the particularcontext, measured differently—such as, but not limited to, angularly,radially, circumferentially (e.g., along an arc), etc.

The terms “monolithic” and “unitary” shall generally refer to an elementor elements made from or consisting of a single structure or baseunit/element. A monolithic and/or unitary element shall excludestructure and/or features made by assembling or otherwise joiningmultiple discrete structures or elements together.

It is noted that references in the specification to “an embodiment”,“some embodiments”, “other embodiments”, etc., indicate that theembodiment(s) described may include a particular feature, structure, orcharacteristic, but every embodiment may not necessarily include theparticular feature, structure, or characteristic. Moreover, such phrasesare not necessarily referring to the same embodiment. Further, when aparticular feature, structure, or characteristic is described inconnection with an embodiment, it would be within the knowledge of oneskilled in the art to effect the particular feature, structure, orcharacteristic in connection with other embodiments, whether or notexplicitly described, unless clearly stated to the contrary. That is,the various individual elements described below, even if not explicitlyshown in a particular combination, are nevertheless contemplated asbeing combinable or arrangeable with each other to form other additionalembodiments or to complement and/or enrich the described embodiment(s),as would be understood by one of ordinary skill in the art.

For the purpose of clarity, certain identifying numerical nomenclature(e.g., first, second, third, fourth, etc.) may be used throughout thedescription and/or claims to name and/or differentiate between variousdescribed and/or claimed features. It is to be understood that thenumerical nomenclature is not intended to be limiting and is exemplaryonly. In some embodiments, alterations of and deviations from previouslyused numerical nomenclature may be made in the interest of brevity andclarity. That is, a feature identified as a “first” element may later bereferred to as a “second” element, a “third” element, etc. or may beomitted entirely, and/or a different feature may be referred to as the“first” element. The meaning and/or designation in each instance will beapparent to the skilled practitioner.

The following figures illustrate selected components and/or arrangementsof an implant for occluding the left atrial appendage, a system foroccluding the left atrial appendage, and/or methods of using the implantand/or the system. It should be noted that in any given figure, somefeatures may not be shown, or may be shown schematically, forsimplicity. Additional details regarding some of the components of theimplant and/or the system may be illustrated in other figures in greaterdetail. While discussed in the context of occluding the left atrialappendage, the implant and/or the system may also be used for otherinterventions and/or percutaneous medical procedures within a patient.Similarly, the devices and methods described herein with respect topercutaneous deployment may be used in other types of surgicalprocedures, as appropriate. For example, in some examples, the devicesmay be used in a non-percutaneous procedure. Devices and methods inaccordance with the disclosure may also be adapted and configured forother uses within the anatomy.

FIGS. 1-2 illustrate selected components and/or arrangements of a system10 for occluding a left atrial appendage 50 (e.g., FIG. 5 ). It shouldbe noted that in any given figure, some features of the system 10 maynot be shown, or may be shown schematically, for simplicity. Additionaldetails regarding some of the components of the system 10 may beillustrated in other figures in greater detail. The system 10 may beused to percutaneously deliver and/or deploy a variety of medicalimplants (e.g., a cardiovascular medical implant, an occlusive medicalimplant, a replacement heart valve implant, etc.) to one or morelocations within the anatomy, including but not limited to, in someembodiments, the heart.

The system 10 may include a delivery sheath 40 having a lumen 42extending from a proximal opening to a distal opening, a core wire 30slidably disposed within the lumen 42, and an implant 100 for occludingthe left atrial appendage 50 (e.g., FIG. 5 ). The implant 100 mayinclude an expandable framework 110 (e.g., FIGS. 3-4 ) configured toshift between a collapsed configuration (e.g., FIG. 1 ), wherein theimplant 100 is disposed within the lumen 42 proximate the distal openingin the collapsed configuration, and an expanded configuration (e.g.,FIG. 2 ), wherein the implant 100 and/or the expandable framework 110 isconfigured to shift between the collapsed configuration and the expandedconfiguration when the implant 100 is disposed distal of the distalopening of the lumen 42 and/or the delivery sheath 40, and/or when theimplant 100 is unconstrained by the delivery sheath 40. In at least someembodiments, the expandable framework 110 may be self-biased toward theexpanded configuration.

The implant 100 may be disposed at and/or releasably securable to adistal portion and/or a distal end of the core wire 30. The core wire 30may be slidably and/or rotatably disposed within the lumen 42 of thedelivery sheath 40. In some embodiments, a proximal end of the core wire30 may extend proximally of a proximal end of the delivery sheath 40and/or the proximal opening of the lumen 42 for manual manipulation by aclinician or practitioner. In some embodiments, the implant 100 may beremovably attached, joined, secured, or otherwise connected to thedistal end of the core wire 30. The core wire 30 may be configured toand/or may be capable of axially translating the implant 100 relative tothe delivery sheath 40. The delivery sheath 40 and/or the core wire 30may have a selected level of axial stiffness and/or pushabilitycharacteristics while also having a selected level of flexibility topermit navigation through the patient's vasculature.

Some suitable, but non-limiting, examples of materials for the system10, the core wire 30, the delivery sheath 40, and/or the implant 100,etc. are discussed below. It is contemplated that any and/or all exampleimplants disclosed herein may be used in accordance with and/or beassociated with the example system 10 described above.

Turning now to FIGS. 3 and 4 , the implant 100 may comprise anexpandable framework 110 configured to shift along a longitudinal axis102 (e.g., FIG. 4 ) between the collapsed configuration and the expandedconfiguration. In the collapsed configuration, the expandable framework110 may be axially elongated and/or radially compressed. In the expandedconfiguration, the expandable framework 110 may be axially shortenedand/or radially expanded. The expandable framework 110 may comprise aplurality of interconnected struts defining a plurality of cells. Insome embodiments, the plurality of cells may be a plurality of closedcells. In some embodiments, the plurality of cells may be a plurality ofopen cells. In some embodiments, the plurality of cells may include aplurality of open cells and a plurality of closed cells in variouscombinations and/or arrangements. In some embodiments, the plurality ofinterconnected struts may converge, join, and/or connect atintersections or nodes.

The plurality of interconnected struts may be formed and/or cut from atubular member. In some embodiments, the plurality of interconnectedstruts may be integrally formed and/or cut from a unitary member. Insome embodiments, the plurality of interconnected struts may beintegrally formed and/or cut from a unitary tubular member andsubsequently formed and/or heat set to a desired shape in the expandedconfiguration. In some embodiments, the plurality of interconnectedstruts may be integrally formed and/or cut from a unitary flat member orsheet, and then rolled or formed into a tubular structure andsubsequently formed and/or heat set to the desired shape in the expandedconfiguration. Some exemplary means and/or methods of making and/orforming the plurality of interconnected struts include laser cutting,machining, punching, stamping, electro discharge machining (EDM),chemical dissolution, etc. Other means and/or methods are alsocontemplated.

In some embodiments, the expandable framework 110 may be compliant andsubstantially conform to and/or be in sealing engagement with the shapeand/or geometry of a lateral wall of the left atrial appendage 50 (e.g.,FIG. 5 ) in the expanded configuration. In some embodiments, the implant100 may expand to a size, extent, or shape less than or different from amaximum unconstrained extent, as determined by the surrounding tissueand/or lateral wall of the left atrial appendage 50. In someembodiments, reducing a thickness of various elements of the expandableframework 110 may increase the flexibility and compliance of theexpandable framework 110 and/or the implant 100, thereby permitting theexpandable framework 110 and/or the implant 100 to conform to the tissuearound it, rather than forcing the tissue to conform to the expandableframework 110 and/or the implant 100. In some embodiments, theexpandable framework 110 and/or the implant 100 may be stronger and/orless compliant, and thus the expandable framework 110 and/or the implant100 may force the tissue of the left atrial appendage 50 to conform tothe expandable framework 110 and/or the implant 100. Otherconfigurations are also contemplated.

The expandable framework 110 may include a proximal hub 112 and a distalhub 114, as seen in FIG. 4 . A longitudinal axis 102 of the expandableframework 110 may extend from the proximal hub 112 to the distal hub114. In at least some embodiments, the proximal hub 112 and/or thedistal hub 114 may be centered on and/or coaxial with the longitudinalaxis 102. The plurality of interconnected struts may be joined togetherat and/or fixedly attached to the proximal hub 112 and/or the distal hub114. The proximal hub 112 may be configured to releasably connect,secure, and/or attach the implant 100 and/or the expandable framework110 to the core wire 30 (e.g., FIGS. 1-2 ). In some embodiments, theproximal hub 112 may include internal threads configured to rotatablyand/or threadably engage an externally threaded distal end of the corewire 30. Other configurations for releasably securing the implant 100 tothe core wire 30 are also contemplated.

Returning to FIG. 3 , in some embodiments, the implant 100 mayoptionally include an occlusive element 120 connected to, disposed on,disposed over, disposed about, and/or disposed radially outward of atleast a portion of the expandable framework 110 and/or the plurality ofinterconnected struts. In some embodiments, the occlusive element 120may be attached to the proximal hub 112 and/or may be attached to theexpandable framework at the proximal hub 112. In some embodiments, theocclusive element 120 may extend radially outward from and/or may extenddistally from the proximal hub 112. In some embodiments, the occlusiveelement 120 may be attached and/or secured to the expandable framework110 at a plurality of discrete locations.

In some embodiments, the occlusive element 120 may include a membrane, afabric, a mesh, a tissue element, or another suitable construction. Insome embodiments, the occlusive element 120 may be porous. In someembodiments, the occlusive element 120 may be non-porous. In someembodiments, the occlusive element 120 may be permeable or impermeableto blood and/or other fluids, such as water. In some embodiments, theocclusive element 120 may be designed, sized, and/or configured toprevent thrombus and/or embolic material from passing out of the leftatrial appendage 50 into the left atrium 58 (e.g., FIG. 5 ) and/or thepatient's bloodstream. In some embodiments, the occlusive element 120(e.g., the membrane, the fabric, or the tissue element, etc.) promotesendothelization after implantation, thereby effectively removing thetarget site (e.g., the left atrial appendage 50, etc.) from thepatient's circulatory system. Some suitable, but non-limiting, examplesof materials for the occlusive element 120 are discussed below.

Turning now to FIGS. 4 and 5 , the implant 100 may include a radiopaquemarker 130. In some embodiments, the radiopaque marker 130 may include aplurality of radiopaque markers 130 spaced apart about a circumferenceof the expandable framework 110. In some embodiments, the implant 100may include a first radiopaque marker 132, a second radiopaque marker134, and a third radiopaque marker 136. More or fewer radiopaque markers130 are also contemplated. For example, the implant 100 may includefour, five, six, eight, ten, twelve, fifteen, eighteen, etc. radiopaquemarkers. In some embodiments, the plurality of radiopaque markers 130may include at least the first radiopaque marker 132, the secondradiopaque marker 134, and the third radiopaque marker 136. In someembodiments, the plurality of radiopaque markers 130 may be equallyspaced apart about the circumference of the expandable framework 110.For example, the plurality of radiopaque markers 130 may be spaced apartabout 120 degrees from each other. Other spacing is also contemplated,and in some embodiments, spacing may be dependent upon how manyradiopaque markers 130 are present. For example, the plurality ofradiopaque markers 130 may be spaced apart about 180 degrees, about 120degrees, about 90 degrees, about 72 degrees, about 60 degrees, about 45degrees, about 30 degrees, etc. In some embodiments, the plurality ofradiopaque markers 130 may be variably spaced apart about thecircumference of the expandable framework 110. Other configurations arealso contemplated.

As may be seen in the side, partial-cross-sectional view of FIG. 5 , theimplant 100 may be positioned within the left atrial appendage 50. Theleft atrial appendage 50 may have a complex geometry and/or irregularsurface area. The left atrial appendage 50 is attached to and in fluidcommunication with the left atrium 58 of the patient's heart. Thoseskilled in the art will recognize that the illustrated left atrialappendage 50 is merely one of many possible shapes and sizes for theleft atrial appendage 50, which may vary from patient to patient. Thoseof skill in the art will also recognize that the medical devices andmethods disclosed herein may be adapted for various sizes and shapes ofthe left atrial appendage 50, as necessary. The left atrial appendage 50may include a generally longitudinal axis arranged along a depth of amain body of the left atrial appendage 50 defined by a lateral wall 54.The left atrial appendage 50 may include the ostium 52 forming aproximal mouth opening into the left atrium 58. In some embodiments, alateral extent of the ostium 52 and/or the lateral wall 54 may besmaller or less than a depth of the main body, or a depth of the mainbody may be greater than a lateral extent of the ostium 56 and/or thelateral wall 54. In some embodiments, the left atrial appendage 50 mayinclude a distalmost region formed or arranged as a tail-like elementassociated with a distal portion of the main body. In some embodiments,the distalmost region may protrude radially or laterally away from themain body.

The radiopaque marker 130 and/or the plurality of radiopaque markers 130may be positioned longitudinally between the proximal hub 112 and thedistal hub 114 in the expanded configuration. For example, theradiopaque marker 130 and/or the plurality of radiopaque markers 130 maybe positioned distal of the proximal hub 112 and proximal of the distalhub 114. In another example, a plane oriented perpendicular to thelongitudinal axis 102 and extending through the radiopaque marker 130and/or the plurality of radiopaque markers 130 may be positioned distalof the proximal hub 112 and proximal of the distal hub 114. In someembodiments, the first radiopaque marker 132 may be positionedlongitudinally between the proximal hub 112 and the distal hub 114 inthe expanded configuration, the second radiopaque marker 134 may bepositioned longitudinally between the proximal hub 112 and the distalhub 114 in the expanded configuration, and the third radiopaque marker136 may be positioned longitudinally between the proximal hub 112 andthe distal hub 114 in the expanded configuration. For example, the firstradiopaque marker 132, the second radiopaque marker 134, and the thirdradiopaque marker 136 may be positioned distal of the proximal hub 112and proximal of the distal hub 114. In another example, a plane orientedperpendicular to the longitudinal axis 102 and extending through thefirst radiopaque marker 132, the second radiopaque marker 134, and/orthe third radiopaque marker 136 may be positioned distal of the proximalhub 112 and proximal of the distal hub 114. In some embodiments, thefirst radiopaque marker 132, the second radiopaque marker 134, and thethird radiopaque marker 136 may define a plane 138 for positioning theexpandable framework 110 in, at, and/or relative to an ostium 52 of theleft atrial appendage 50 in the expanded configuration.

In some embodiments, the radiopaque marker 130 and/or the plurality ofradiopaque markers 130 may be used as fiducial markers to watch theirposition under fluoroscopy (or another type of imaging) relative to somebackground anatomy (e.g., ribs, etc.) when a tug test is performed toassess anchoring. If the radiopaque marker 130 and/or the plurality ofradiopaque markers 130 are positioned at a starting location and end inanother location, the imaging will show that the implant 100 and/or theexpandable framework 110 has shifted. Alternatively, if the radiopaquemarker 130 and/or the plurality of radiopaque markers 130 remain fixedat the starting location after the test, the implant 100 and/or theexpandable framework 110 has not moved and in anchored securely.

In some embodiments, the plurality of radiopaque markers 130 may be usedas deployment aids. For example, as the implant 100 and/or theexpandable framework 110 exits the delivery sheath 40 and/or when theexpandable framework 110 begins to shift to the expanded configuration,the plurality of radiopaque markers 130 may begin to move apart fromeach other under fluoroscopy (or another type of imaging) and indicatethat the implant 100 and/or the expandable framework 110 is openingand/or nearing the final stages of deployment. In some embodiments, theplurality of radiopaque markers 130 may help the physician locate theimplant 100 during deployment such that an idealized position may beachieved during initial deployment.

In some embodiments, the plurality of radiopaque markers 130 may be usedto take size measurements for compression under fluoroscopy (or anothertype of imaging). In some embodiments, the plurality of radiopaquemarkers 130 may be used to ensure sealing of the implant 100 against theostium 52 and/or the lateral wall 54 of the left atrial appendage 50when a contrast puff is also used. Other configurations and/or uses arealso contemplated.

As noted above, in order to facilitate understanding, certain featuresof the disclosure may be described in the singular, even though thosefeatures may be plural or recurring within the disclosed embodiment(s).Each instance of the features may include and/or be encompassed by thesingular disclosure(s), unless expressly stated to the contrary. Forsimplicity and clarity purposes, not all elements of the presentdisclosure are necessarily shown in each figure or discussed in detailbelow. However, it will be understood that the following discussion mayapply equally to any and/or all of the components for which there aremore than one, unless explicitly stated to the contrary. As such, anyone of and/or every one of the plurality of radiopaque markers 130and/or the first radiopaque marker 132, the second radiopaque marker134, and the third radiopaque marker 136, etc. may be encompassed by thecurrent disclosure.

FIG. 6 illustrates one configuration of the radiopaque marker 130(and/or the plurality of radiopaque markers 130; the first radiopaquemarker 132, the second radiopaque marker 134, and the third radiopaquemarker 136, etc.) as viewed from outside of the implant 100 and/or theexpandable framework 110. In some embodiments, the radiopaque marker 130may include a body portion 140. In some embodiments, the radiopaquemarker may include a proximal leg 142 and a distal leg 144. In someembodiments, the radiopaque marker may include a first lateral tab 146and a second lateral tab 152. In at least some embodiments, the bodyportion 140 may be disposed and/or positioned against an exteriorsurface of the expandable framework 110. In some alternativeembodiments, the body portion 140 may be disposed and/or positionedagainst an interior surface of the expandable framework 110. Otherconfigurations are also contemplated.

In some embodiments, the body portion 140 may be positioned at and/oragainst an intersection or node of the plurality of interconnectedstruts of the expandable framework 110. In some embodiments, the bodyportion 140 may be positioned at and/or against a radially outermostintersection or node of the plurality of interconnected struts of theexpandable framework 110. In some embodiments, the body portion 140 maybe positioned at and/or against a proximalmost intersection or node ofthe plurality of interconnected struts of the expandable framework 110.Other configurations are also contemplated.

As seen in the cross-sectional view of FIG. 7 , the first lateral tab146 may extend laterally from the body portion 140 in a first direction.The second lateral tab 152 may extend laterally from the body portion140 in a second direction opposite the first direction. In someembodiments, a first medial portion 148 of the first lateral tab 146 mayextend in the first direction from the body portion 140. The firstmedial portion 148 of the first lateral tab 146 may extend radiallyinward toward the longitudinal axis 102 and/or toward an interior of theimplant 100 and/or the expandable framework 110. In some embodiments, asecond medial portion 154 of the second lateral tab 152 may extend inthe second direction from the body portion 140. The second medialportion 154 of the second lateral tab 152 may extend radially inwardtoward the longitudinal axis 102 and/or toward the interior of theimplant 100 and/or the expandable framework 110. In some embodiments, afirst free end 150 of the first lateral tab 146 may extend laterally inthe second direction from the first medial portion 148 of the firstlateral tab 146. In some embodiments, a second free end 156 of thesecond lateral tab 152 may extend laterally in the first direction fromthe second medial portion 154 of the second lateral tab 152. In someembodiments, the first lateral tab 146 and the second lateral tab 152may wrap around a portion of the expandable framework 110. For example,the first lateral tab 146 and the second lateral tab 152 may wrap aroundan intersection or node of the plurality of interconnected struts of theexpandable framework 110. In some embodiments, at least a portion of thesecond free end 156 of the second lateral tab 152 may overlap the firstfree end 150 of the first lateral tab 146. In some embodiments, at leasta portion of the second lateral tab 152 may extend radially inwardlycloser to the longitudinal axis 102 than the first lateral tab 146. Insome embodiments, the second free end 156 of the second lateral tab 152may extend radially inwardly closer to the longitudinal axis 102 thanthe first free end 150 of the first lateral tab 146. In someembodiments, the first free end 150 of the first lateral tab 146 mayabut the second free end 156 of the second lateral tab 152. In suchembodiments, the first free end 150 and the second free end 156 may besubstantially equidistant from the longitudinal axis 102. Otherconfigurations are also contemplated.

Returning briefly to FIG. 6 , the radiopaque marker 130 (and/or theplurality of radiopaque markers 130 and/or the first radiopaque marker132, the second radiopaque marker 134, and the third radiopaque marker136, etc.) may define a lateral extent 160 and a longitudinal extent162. In at least some embodiments, the longitudinal extent 162 may begreater than the lateral extent 160. The longitudinal extent 162 may beoriented longitudinally with respect to the expandable framework 110.Other configurations are also contemplated.

As seen in FIGS. 6 and 8 , the proximal leg 142 may extend from the bodyportion 140 longitudinally toward a proximal end of the implant 100and/or the expandable framework 110 and/or the proximal leg 142 mayextend from the body portion 140 radially inward toward the longitudinalaxis 102 and/or toward the interior of the implant 100 and/or theexpandable framework 110. The distal leg 144 may extend from the bodyportion 140 longitudinally toward a distal end of the implant 100 and/orthe expandable framework 110 and/or the distal leg 144 may extend fromthe body portion 140 radially inward toward the longitudinal axis 102and/or toward the interior of the implant 100 and/or the expandableframework 110.

In some embodiments, the proximal leg 142 may extend from the bodyportion 140 radially inward toward the longitudinal axis 102 and/ortoward the interior of the implant 100 and/or the expandable framework110 until a free end of the proximal leg 142 is disposed radially inwardof an interior surface of the expandable framework 110. In someembodiments, the proximal leg 142 may extend from the body portion 140radially inward toward the longitudinal axis 102 and/or toward theinterior of the implant 100 and/or the expandable framework 110 untilthe free end of the proximal leg 142 is disposed substantially flushwith the interior surface of the expandable framework 110. In someembodiments, the distal leg 144 may extend from the body portion 140radially inward toward the longitudinal axis 102 and/or toward theinterior of the implant 100 and/or the expandable framework 110 until afree end of the distal leg 144 is disposed radially inward of aninterior surface of the expandable framework 110. In some embodiments,the distal leg 144 may extend from the body portion 140 radially inwardtoward the longitudinal axis 102 and/or toward the interior of theimplant 100 and/or the expandable framework 110 until the free end ofthe distal leg 144 is disposed substantially flush with the interiorsurface of the expandable framework 110. Other configurations are alsocontemplated.

In some embodiments, the radiopaque marker 130 may be made by punchingand/or stamping the radiopaque marker 130 from a flat sheet or strip ofmaterial and then formed using one or more suitable methods. In someembodiments, the radiopaque marker 130 may be laser cut from a flatsheet or strip of material and then formed using one or more suitablemethods. In some embodiments, the radiopaque marker 130 may be formed bydie casting, injection molding, etc. In some embodiments, the radiopaquemarker 130 may be cut and formed using a progressive die in a stampingmachine or other similar methods. In some embodiments, the radiopaquemarker 130 may be crimped onto the expandable framework 110. In someembodiments, the radiopaque marker 130 may be bonded and/or welded tothe expandable framework 110. Other configurations and/or methods arealso contemplated.

In some embodiments, the radiopaque marker 130 may be formed from adifferent material than the expandable framework 110. In someembodiments, the radiopaque marker 130 may have a different density thanthe expandable framework 110. In at least some embodiments, theradiopaque marker 130 may have a greater density than the expandableframework 110. Some suitable, but non-limiting, examples of materialsfor the radiopaque marker 130, the plurality of radiopaque markers 130,the first radiopaque marker 132, the second radiopaque marker 134, andthe third radiopaque marker 136, etc., are discussed below.

As discussed above, the system 10 for occluding the left atrialappendage 50 may include the delivery sheath 40 having the lumen 42extending therein and the core wire 30 slidably disposed within thelumen 42 of the delivery sheath 40. When preparing for a procedure, theimplant 100 needs to be moved into the lumen 42 of the delivery sheath40. In some instances, the implant 100 may need to be re-sheathed and/ormoved back into the lumen 42 of the delivery sheath 40 in situ, such aswhen the implant 100 needs to be repositioned and/or removed prior torelease. FIG. 9 illustrates selected aspects of the system 10 and/or theimplant 100 when the implant 100 is being moved into the lumen 42 of thedelivery sheath 40. All elements and/or features of the implant 100 arenot shown (or are not shown completely) in order to improve clarity.

As may be seen in FIG. 9 , when the implant 100 is being moved into thelumen 42 of the delivery sheath 40, the proximal leg 142 of theradiopaque marker 130 (and/or the plurality of radiopaque markers 130,the first radiopaque marker 132, the second radiopaque marker 134, andthe third radiopaque marker 136, etc.) may engage a distalmost end 44 ofthe delivery sheath 40 and act as a ramp to guide and/or urge theexpandable framework 110 radially inward and away from an inner surfaceof the delivery sheath 40. In at least some embodiments, the occlusiveelement 120 may be disposed between the radiopaque marker 130 (and/orthe plurality of radiopaque markers 130, the first radiopaque marker132, the second radiopaque marker 134, and the third radiopaque marker136, etc.) and/or the proximal leg 142 and the distalmost end 44 of thedelivery sheath 40. However, the occlusive element 120 fails tonegatively affect the ramping and/or guiding function of the proximalleg 142 of the radiopaque marker 130 (and/or the plurality of radiopaquemarkers 130, the first radiopaque marker 132, the second radiopaquemarker 134, and the third radiopaque marker 136, etc.).

FIG. 10 illustrates an alternative configuration of a radiopaque marker230 associated with the implant 100. In accordance with the rest of thedisclosure, in some embodiments, the radiopaque marker 230 may include aplurality of radiopaque markers 230 and/or a first radiopaque marker, asecond radiopaque marker, a third radiopaque marker, etc. and isdiscussed in the singular in the interest of brevity. The radiopaquemarker 230 may include a tubular member 240 disposed radially inward ofan inner surface of the expandable framework 110. In some embodiments,the radiopaque marker 230 and/or the tubular member 240 may be securedagainst the inner surface of the expandable framework 110. In someembodiments, the radiopaque marker 230 and/or the tubular member 240 maybe positioned at and/or against an intersection or node of the pluralityof interconnected struts of the expandable framework 110. In someembodiments, the radiopaque marker 230 and/or the tubular member 240 maybe positioned at and/or against a radially outermost intersection ornode of the plurality of interconnected struts of the expandableframework 110. In some embodiments, the radiopaque marker 230 and/or thetubular member 240 may be positioned at and/or against a proximalmostintersection or node of the plurality of interconnected struts of theexpandable framework 110. Other configurations are also contemplated.

In some embodiments, the radiopaque marker 230 and/or the tubular member240 may be secured to and/or against the expandable framework 110 usinga filament 244 extending through a lumen 242 of the tubular member 240and/or the radiopaque marker 230. In some embodiments, the filament 244may be a suture, a wire, or other suitable element. In some embodiments,the filament 244 may be secured and/or fixed together at a securementelement 246. The securement element 246 may be a knot, a weld, oranother means of securing the filament 244. Other configurations arealso contemplated.

In some embodiments, the radiopaque marker 230 (and/or the plurality ofradiopaque markers 230 and/or the first radiopaque marker, the secondradiopaque marker, and the third radiopaque marker, etc.) and/or thetubular member 240 may define a lateral extent and a longitudinalextent. In at least some embodiments, the longitudinal extent may begreater than the lateral extent. The longitudinal extent may be orientedlongitudinally with respect to the expandable framework 110. Otherconfigurations are also contemplated.

FIG. 11 illustrates an alternative configuration of a radiopaque marker330 associated with the implant 100. In accordance with the rest of thedisclosure, in some embodiments, the radiopaque marker 330 may include aplurality of radiopaque markers 330 and/or a first radiopaque marker, asecond radiopaque marker, a third radiopaque marker, etc. and isdiscussed in the singular in the interest of brevity. The radiopaquemarker 330 may include a flat plate 340 disposed radially inward of aninner surface of the expandable framework 110. In some embodiments, theradiopaque marker 330 and/or the flat plate 340 may be secured againstthe inner surface of the expandable framework 110. In some embodiments,the radiopaque marker 330 and/or the flat plate 340 may be positioned atand/or against an intersection or node of the plurality ofinterconnected struts of the expandable framework 110. In someembodiments, the radiopaque marker 330 and/or the flat plate 340 may bepositioned at and/or against a radially outermost intersection or nodeof the plurality of interconnected struts of the expandable framework110. In some embodiments, the radiopaque marker 330 and/or the flatplate 340 may be positioned at and/or against a proximalmostintersection or node of the plurality of interconnected struts of theexpandable framework 110. Other configurations are also contemplated.

In some embodiments, the radiopaque marker 330 and/or the flat plate 340may be secured to and/or against the expandable framework 110 using afilament 344. In some embodiments, the filament 344 may be a suture, awire, or other suitable element. In some embodiments, the filament 344may pass through one or more apertures in the flat plate 340. In someembodiments, the filament 344 may be secured and/or fixed to the flatplate 340 at one or more securement elements 346. The one or moresecurement elements 346 may be a knot, a weld, or another means ofsecuring the filament 344. In one example, the filament 344 may be awire that is welded to the flat plate 340 at the one or more securementelements 346. Other configurations are also contemplated.

In some embodiments, the radiopaque marker 330 (and/or the plurality ofradiopaque markers 330 and/or the first radiopaque marker, the secondradiopaque marker, and the third radiopaque marker, etc.) and/or theflat plate 340 may define a lateral extent and a longitudinal extent. Inat least some embodiments, the longitudinal extent may be greater thanthe lateral extent. The longitudinal extent may be orientedlongitudinally with respect to the expandable framework 110. Otherconfigurations are also contemplated.

FIG. 12 illustrates an alternative configuration of a radiopaque marker430 associated with the implant 100 and/or the occlusive element 120. Inaccordance with the rest of the disclosure, in some embodiments, theradiopaque marker 430 may include a plurality of radiopaque markers 430and/or a first radiopaque marker, a second radiopaque marker, a thirdradiopaque marker, etc. and is discussed in the singular in the interestof brevity. The radiopaque marker 430 may include a flattened element440 disposed radially outward of the exterior surface of the expandableframework 110. In some embodiments, the radiopaque marker 430 and/or theflattened element 440 may be positioned at and/or over an intersectionor node of the plurality of interconnected struts of the expandableframework 110. In some embodiments, the radiopaque marker 430 and/or theflattened element 440 may be positioned at and/or over a radiallyoutermost intersection or node of the plurality of interconnected strutsof the expandable framework 110. In some embodiments, the radiopaquemarker 430 and/or the flattened element 440 may be positioned at and/orover a proximalmost intersection or node of the plurality ofinterconnected struts of the expandable framework 110. Otherconfigurations are also contemplated.

In contrast to other examples described herein, the radiopaque marker430 and/or the flattened element 440 may be secured to and/or fixedlyattached to the occlusive element 120. In some embodiments, theradiopaque marker 430 and/or the flattened element 440 may be at leastpartially embedded within the occlusive element 120. In someembodiments, the flattened element 440 may be partially exposed to theinside, as seen in FIG. 13 , or the outside of the occlusive element120. In some embodiments, the flattened element 440 may be completelyembedded within the occlusive element 120.

In some embodiments, the occlusive element 120 may include a first layer122 and a second layer 124. In some embodiments, at least a portion ofthe flattened element 440 may be disposed between the first layer 122and the second layer 124 of the occlusive element 120. In someembodiments, the first layer 122 and the second layer 124 of theocclusive element 120 may be fixedly attached to each other. In oneexample, the first layer 122 of the occlusive element 120 may be bondedto the second layer 124 of the occlusive element 120. In anotherexample, the first layer 122 of the occlusive element 120 may be weldedto the second layer 124 of the occlusive element 120. Otherconfigurations are also contemplated.

In some embodiments, an outwardly facing surface of the flattenedelement 440 may be engaged against, bonded to, and/or may face aninwardly facing surface of the occlusive element 120, and an inwardlyfacing surface of the flattened element 440 may face away from theocclusive element 120 and/or may facing toward the interior of theimplant 100 and/or the expandable framework 110. Other configurationsare also contemplated.

In some embodiments, the flattened element 440 may include a firstflange 442 at and/or proximate a proximal end of the flattened element440 and a second flange 444 at and/or proximate a distal end of theflattened element 440. In some embodiments, the first flange 442 and/orthe second flange 444 may be embedded within the occlusive element 120and/or may be disposed between the first layer 122 and the second layer124 of the occlusive element 120. In some embodiments, an outwardlyfacing surface of the first flange 442 may face towards the first layer122 of the occlusive element 120 and an inwardly facing surface of thefirst flange 442 may face towards the second layer 124 of the occlusiveelement 120. In some embodiments, an outwardly facing surface of thesecond flange 444 may face towards the first layer 122 of the occlusiveelement 120 and an inwardly facing surface of the second flange 444 mayface towards the second layer 124 of the occlusive element 120. Otherconfigurations are also contemplated.

In some embodiments, the first flange 442 of the flattened element 440may be fixedly attached to the first layer 122 and/or the second layer124 of the occlusive element 120. In some embodiments, the second flange444 of the flattened element 440 may be fixedly attached to the firstlayer 122 and/or the second layer 124 of the occlusive element 120. Insome embodiments, the first flange 442 of the flattened element 440 andthe second flange 444 of the flattened element 440 may be fixedlyattached to the first layer 122 and/or the second layer 124 of theocclusive element 120. Other configurations are also contemplated.

In some embodiments, the radiopaque marker 430 (and/or the plurality ofradiopaque markers 430 and/or the first radiopaque marker, the secondradiopaque marker, and the third radiopaque marker, etc.) and/or theflattened element 440 may define a lateral extent and a longitudinalextent. In at least some embodiments, the longitudinal extent may begreater than the lateral extent. The longitudinal extent may be orientedlongitudinally with respect to the expandable framework 110. Otherconfigurations are also contemplated.

The materials that can be used for the various components of the system(and/or other elements disclosed herein) and the various componentsthereof disclosed herein may include those commonly associated withmedical devices and/or systems. For simplicity purposes, the followingdiscussion refers to the system. However, this is not intended to limitthe devices and methods described herein, as the discussion may beapplied to other elements, members, components, or devices disclosedherein, such as, but not limited to, the implant, the delivery sheath,the core wire, the expandable framework, the occlusive element, etc.and/or elements or components thereof.

In some embodiments, the system and/or components thereof may be madefrom a metal, metal alloy, polymer (some examples of which are disclosedbelow), a metal-polymer composite, ceramics, combinations thereof, andthe like, or other suitable material.

Some examples of suitable metals and metal alloys include stainlesssteel, such as 444V, 444L, and 314LV stainless steel; mild steel;nickel-titanium alloy such as linear-elastic and/or super-elasticnitinol; other nickel alloys such as nickel-chromium-molybdenum alloys(e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY®C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys,and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL®400, NICKELVAC® 400, NICORROS® 400, and the like),nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such asMP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 suchas HASTELLOY® ALLOY B2®), other nickel-chromium alloys, othernickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-ironalloys, other nickel-copper alloys, other nickel-tungsten or tungstenalloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenumalloys (e.g., UNS: R44003 such as ELGILOY®, PHYNOX®, and the like);platinum enriched stainless steel; titanium; combinations thereof; andthe like; or any other suitable material.

As alluded to herein, within the family of commercially availablenickel-titanium or nitinol alloys, is a category designated “linearelastic” or “non-super-elastic” which, although may be similar inchemistry to conventional shape memory and super elastic varieties, mayexhibit distinct and useful mechanical properties. Linear elastic and/ornon-super-elastic nitinol may be distinguished from super elasticnitinol in that the linear elastic and/or non-super-elastic nitinol doesnot display a substantial “superelastic plateau” or “flag region” in itsstress/strain curve like super elastic nitinol does. Instead, in thelinear elastic and/or non-super-elastic nitinol, as recoverable strainincreases, the stress continues to increase in a substantially linear,or a somewhat, but not necessarily entirely linear relationship untilplastic deformation begins or at least in a relationship that is morelinear than the super elastic plateau and/or flag region that may beseen with super elastic nitinol. Thus, for the purposes of thisdisclosure linear elastic and/or non-super-elastic nitinol may also betermed “substantially” linear elastic and/or non-super-elastic nitinol.

In some cases, linear elastic and/or non-super-elastic nitinol may alsobe distinguishable from super elastic nitinol in that linear elasticand/or non-super-elastic nitinol may accept up to about 2-5% strainwhile remaining substantially elastic (e.g., before plasticallydeforming) whereas super elastic nitinol may accept up to about 8%strain before plastically deforming. Both of these materials can bedistinguished from other linear elastic materials such as stainlesssteel (that can also be distinguished based on its composition), whichmay accept only about 0.2 to 0.44 percent strain before plasticallydeforming.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy is an alloy that does not show anymartensite/austenite phase changes that are detectable by differentialscanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA)analysis over a large temperature range. For example, in someembodiments, there may be no martensite/austenite phase changesdetectable by DSC and DMTA analysis in the range of about −60 degreesCelsius (° C.) to about 120° C. in the linear elastic and/ornon-super-elastic nickel-titanium alloy. The mechanical bendingproperties of such material may therefore be generally inert to theeffect of temperature over this very broad range of temperature. In someembodiments, the mechanical bending properties of the linear elasticand/or non-super-elastic nickel-titanium alloy at ambient or roomtemperature are substantially the same as the mechanical properties atbody temperature, for example, in that they do not display asuper-elastic plateau and/or flag region. In other words, across a broadtemperature range, the linear elastic and/or non-super-elasticnickel-titanium alloy maintains its linear elastic and/ornon-super-elastic characteristics and/or properties.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy may be in the range of about 50 to about 60 weightpercent nickel, with the remainder being essentially titanium. In someembodiments, the composition is in the range of about 54 to about 57weight percent nickel. One example of a suitable nickel-titanium alloyis FHP-NT alloy commercially available from Furukawa Techno Material Co.of Kanagawa, Japan. Other suitable materials may include ULTANIUM™(available from Neo-Metrics) and GUM METAL™ (available from Toyota). Insome other embodiments, a superelastic alloy, for example a superelasticnitinol can be used to achieve desired properties.

In at least some embodiments, portions or all of the system and/or otherelements disclosed herein may also be doped with, made of, or otherwiseinclude a radiopaque material. Radiopaque materials are understood to bematerials capable of producing a relatively bright image on afluoroscopy screen or another imaging technique during a medicalprocedure. This relatively bright image aids a user in determining thelocation and/or orientation of the system and/or other elementsdisclosed herein. Some examples of radiopaque materials can include, butare not limited to, gold, platinum, palladium, tantalum, tungsten alloy,polymer material loaded with a radiopaque filler, and the like.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI)compatibility is imparted into the system and/or other elementsdisclosed herein. For example, the system and/or components or portionsthereof may be made of a material that does not substantially distortthe image and create substantial artifacts (e.g., gaps in the image).Certain ferromagnetic materials, for example, may not be suitablebecause they may create artifacts in an MRI image. The system orportions thereof, may also be made from a material that the MRI machinecan image. Some materials that exhibit these characteristics include,for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R44003 such as ELGILOY®, PHYNOX®, and the like),nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such asMP35-N® and the like), nitinol, and the like, and others.

In some embodiments, the system and/or other elements disclosed hereinmay be made from or include a polymer or other suitable material. Someexamples of suitable polymers may include polytetrafluoroethylene(PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylenepropylene (FEP), polyoxymethylene (POM, for example,

DELRIN® available from DuPont), polyether block ester, polyurethane (forexample, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC),polyether-ester (for example, ARNITEL® available from DSM EngineeringPlastics), ether or ester based copolymers (for example,butylene/poly(alkylene ether) phthalate and/or other polyesterelastomers such as HYTREL® available from DuPont), polyamide (forexample, DURETHAN® available from Bayer or CRISTAMID® available from ElfAtochem), elastomeric polyamides, block polyamide/ethers, polyetherblock amide (PEBA, for example available under the trade name PEBAX®),ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE),MARLEX® high-density polyethylene, MARLEX® low-density polyethylene,linear low density polyethylene (for example REXELL®), polyester,polybutylene terephthalate (PBT), polyethylene terephthalate (PET),polytrimethylene terephthalate, polyethylene naphthalate (PEN),polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI),polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (for example, KEVLAR®), polysulfone,nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon),perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin,polystyrene, epoxy, polyvinylidene chloride (PVdC),poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS50A), polycarbonates, ionomers, biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like. In some embodiments the sheath can be blendedwith a liquid crystal polymer (LCP). For example, the mixture cancontain up to about 6 percent LCP.

In some embodiments, the system and/or other elements disclosed hereinmay include a fabric material disposed over or within the structure. Thefabric material may be composed of a biocompatible material, such apolymeric material or biomaterial, adapted to promote tissue ingrowth.In some embodiments, the fabric material may include a bioabsorbablematerial. Some examples of suitable fabric materials include, but arenot limited to, polyethylene glycol (PEG), nylon,polytetrafluoroethylene (PTFE, ePTFE), a polyolefinic material such as apolyethylene, a polypropylene, polyester, polyurethane, and/or blends orcombinations thereof.

In some embodiments, the system and/or other elements disclosed hereinmay include and/or be formed from a textile material. Some examples ofsuitable textile materials may include synthetic yarns that may be flat,shaped, twisted, textured, pre-shrunk or un-shrunk. Syntheticbiocompatible yarns suitable for use in the present disclosure include,but are not limited to, polyesters, including polyethylene terephthalate(PET) polyesters, polypropylenes, polyethylenes, polyurethanes,polyolefins, polyvinyls, polymethylacetates, polyamides, naphthalenedicarboxylene derivatives, natural silk, and polytetrafluoroethylenes.Moreover, at least one of the synthetic yarns may be a metallic yarn ora glass or ceramic yarn or fiber. Useful metallic yarns include thoseyarns made from or containing stainless steel, platinum, gold, titanium,tantalum or a Ni—Co—Cr-based alloy. The yarns may further includecarbon, glass or ceramic fibers. Desirably, the yarns are made fromthermoplastic materials including, but not limited to, polyesters,polypropylenes, polyethylenes, polyurethanes, polynaphthalenes,polytetrafluoroethylenes, and the like. The yarns may be of themultifilament, monofilament, or spun types. The type and denier of theyarn chosen may be selected in a manner which forms a biocompatible andimplantable prosthesis and, more particularly, a vascular structurehaving desirable properties.

In some embodiments, the system and/or other elements disclosed hereinmay include and/or be treated with a suitable therapeutic agent. Someexamples of suitable therapeutic agents may include anti-thrombogenicagents (such as heparin, heparin derivatives, urokinase, and PPack(dextrophenylalanine proline arginine chloromethylketone));anti-proliferative agents (such as enoxaparin, angiopeptin, monoclonalantibodies capable of blocking smooth muscle cell proliferation,hirudin, and acetylsalicylic acid); anti-inflammatory agents (such asdexamethasone, prednisolone, corticosterone, budesonide, estrogen,sulfasalazine, and mesalamine);antineoplastic/antiproliferative/anti-mitotic agents (such aspaclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine,epothilones, endostatin, angiostatin and thymidine kinase inhibitors);anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine);anti-coagulants (such as D-Phe-Pro-Arg chloromethyl ketone, an RGDpeptide-containing compound, heparin, anti-thrombin compounds, plateletreceptor antagonists, anti-thrombin antibodies, anti-platelet receptorantibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, andtick antiplatelet peptides); vascular cell growth promoters (such asgrowth factor inhibitors, growth factor receptor antagonists,transcriptional activators, and translational promoters); vascular cellgrowth inhibitors (such as growth factor inhibitors, growth factorreceptor antagonists, transcriptional repressors, translationalrepressors, replication inhibitors, inhibitory antibodies, antibodiesdirected against growth factors, bifunctional molecules consisting of agrowth factor and a cytotoxin, bifunctional molecules consisting of anantibody and a cytotoxin); cholesterol-lowering agents; vasodilatingagents; and agents which interfere with endogenous vasoactivemechanisms.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps, without exceeding the scope ofthe disclosure. This may include, to the extent that it is appropriate,the use of any of the features of one example embodiment being used inother embodiments. The disclosure's scope is, of course, defined in thelanguage in which the appended claims are expressed.

What is claimed is:
 1. An implant for occluding a left atrial appendage,comprising: an expandable framework configured to shift between acollapsed configuration and an expanded configuration; wherein theexpandable framework includes a proximal hub and a distal hub; wherein alongitudinal axis of the expandable framework extends from the proximalhub to the distal hub; and a radiopaque marker positioned longitudinallybetween the proximal hub and the distal hub in the expandedconfiguration.
 2. The implant of claim 1, wherein the radiopaque markeris oriented longitudinally in the expanded configuration.
 3. The implantof claim 1, wherein the radiopaque marker includes a body portion, aproximal leg, a distal leg, a first lateral tab, and a second lateraltab; wherein the body portion is disposed against an exterior surface ofthe expandable framework.
 4. The implant of claim 3, wherein theproximal leg and the distal leg extend radially inwardly toward aninterior of the expandable framework.
 5. The implant of claim 3, whereinthe first lateral tab and the second lateral tab wrap around a portionof the expandable framework.
 6. The implant of claim 1, wherein theradiopaque marker includes a tubular member disposed radially inward ofand secured against an inner surface of the expandable framework.
 7. Theimplant of claim 1, wherein the radiopaque marker includes a flat platedisposed radially inward of and secured against an inner surface of theexpandable framework.
 8. The implant of claim 1, further comprising anocclusive element disposed over at least a portion of the expandableframework.
 9. The implant of claim 8, wherein the radiopaque markerincludes a flattened element at least partially embedded within theocclusive element.
 10. The implant of claim 1, wherein the radiopaquemarker includes a plurality of radiopaque markers spaced apart about acircumference of the expandable framework.
 11. A system for occluding aleft atrial appendage, comprising: a delivery sheath and core wireslidably disposed within a lumen of the delivery sheath; and an implantfor occluding a left atrial appendage releasably securable to a distalend of the core wire, the implant comprising: an expandable frameworkconfigured to shift between a collapsed configuration and an expandedconfiguration; wherein the expandable framework includes a proximal huband a distal hub; wherein a longitudinal axis of the expandableframework extends from the proximal hub to the distal hub; and aradiopaque marker positioned longitudinally between the proximal hub andthe distal hub in the expanded configuration.
 12. The system of claim11, wherein the radiopaque marker is formed from a different materialthan the expandable framework.
 13. The system of claim 11, wherein theradiopaque marker has a different density than the expandable framework.14. The system of claim 11, wherein the radiopaque marker includes abody portion, a proximal leg, and a distal leg; wherein the body portionis disposed against an exterior surface of the expandable framework;wherein the proximal leg and the distal leg extend radially inwardlytoward an interior of the expandable framework; wherein when the implantis being moved into the lumen, the proximal leg engages the deliverysheath to urge the expandable framework radially inward and away fromthe delivery sheath.
 15. A system for occluding a left atrial appendage,comprising: a delivery sheath and a core wire slidably disposed within alumen of the delivery sheath; and an implant for occluding a left atrialappendage releasably securable to a distal end of the core wire, theimplant comprising: an expandable framework configured to shift betweena collapsed configuration and an expanded configuration; wherein theexpandable framework includes a proximal hub and a distal hub; wherein alongitudinal axis of the expandable framework extends from the proximalhub to the distal hub; a first radiopaque marker positionedlongitudinally between the proximal hub and the distal hub in theexpanded configuration; a second radiopaque marker positionedlongitudinally between the proximal hub and the distal hub in theexpanded configuration; and a third radiopaque marker positionedlongitudinally between the proximal hub and the distal hub in theexpanded configuration; wherein the first radiopaque marker, the secondradiopaque marker, and the third radiopaque marker define a plane forpositioning the expandable framework relative to an ostium of the leftatrial appendage in the expanded configuration.
 16. The system of claim15, wherein the first, second, and third radiopaque markers eachincludes a body portion, a proximal leg, and a distal leg; wherein thebody portion is disposed against an exterior surface of the expandableframework; wherein the proximal leg and the distal leg extend radiallyinwardly toward an interior of the expandable framework; wherein whenthe implant is being moved into the lumen, the proximal leg engages thedelivery sheath to urge the expandable framework radially inward andaway from the delivery sheath.
 17. The system of claim 16, wherein thefirst, second, and third radiopaque markers each further includes afirst lateral tab and a second lateral tab; wherein the first lateraltab and the second lateral tab wrap around a portion of the expandableframework.
 18. The system of claim 17, wherein at least a portion of thesecond lateral tab overlaps the first lateral tab.
 19. The system ofclaim 17, wherein at least a portion of the second lateral tab extendsradially inward closer to the longitudinal axis than the first lateraltab.
 20. The system of claim 15, wherein the first, second, and thirdradiopaque markers each define a lateral extent and a longitudinalextent, the longitudinal extent being greater than the lateral extent;wherein the longitudinal extent is oriented longitudinally with respectto the expandable framework.